Customizable face or nose mask for the noninvasive ventilation of patients in general

ABSTRACT

A customizable face or nose mask for the noninvasive ventilation of patients in general, which comprises a mask body forming at least one surface portion which can be coupled to the face of the patient. The peculiarity of the invention consists in that it comprises, at least at the surface portion, a chamber for containing at least one product without shape memory which can be activated to produce a chemical and/or physical reaction for the transformation of the at least one product without shape memory into a product having shape memory which spontaneously models itself on the patient&#39;s face.

RELATED APPLICATIONS

This is a continuation of Ser. No. 09/674,963 filed Nov. 3, 2000 nowU.S. Pat. No. 6,494,206 which is a 371 of PCT/US99/10300 filed May11,1999.

The present invention relates to a customizable face or nose mask forthe noninvasive ventilation of patients in general.

It is known that the noninvasive ventilation of patients in general isbased on the use of a face or nose mask which is applied by exerting apositive pressure so as to provide the intended seal at the perimetricedges of the mask in contact with the patient's face.

One of the most severe problems to be overcome is the patient'stolerance of the machine-face interface, which is constituted by themask proper.

Due to the considerable anatomical diversity of faces, it is necessaryto apply a certain force to the mask in order to ensure its tightness;accordingly, though using of very soft materials, in the long term thepressure on the face leads to more or less severe traumas for thepatient.

Markedly better results have been achieved by using masks which areproduced starting from a mold formed on the patient's face; essentially,a mold of the patient's face is made and a relatively soft material,generally silicone, is then poured onto said mold; the material assumesthe anatomical shape of the patient's face and accordingly minimalpressure is sufficient to provide the intended seal against the face.

Although these embodiments are valid from a functional point of view,they suffer the severe drawback of having an exceptionally high cost,since it is necessary to provide a specific mold to form the mask ineach individual case.

These solutions furthermore require relatively long production times;together with their high costs, these factors have led to a limiteddiffusion of these types of mask.

The aim of the invention is to provide a customizable face or nose maskfor the noninvasive ventilation of patients in general, which can bemodeled directly on the individual patient without thereby requiring themaking of a mold.

Within the scope of this aim, a particular object of the invention is toprovide a customizable mask in which it is possible to performadaptation to the individual patient in a very short time without havingto resort to special devices.

Another object of the present invention is to provide a customizablemask which, by way of its particular constructive features, is capableof giving the greatest assurances of reliability and safety in use.

Another object of the present invention is to provide a customizablemask which can be easily obtained starting from commonly commerciallyavailable elements and materials and is also inexpensive, thuscontributing to the diffusion of the mask among users.

This aim, these objects and others which will become apparenthereinafter are achieved by a customizable face or nose mask for thenoninvasive ventilation of patients in general, which comprises a maskbody forming at least one surface portion which can be coupled to theface of the patient, characterized in that it comprises, at least atsaid surface portion, a chamber for containing at least one productwithout shape memory which can be activated to produce a chemical and/orphysical reaction for the transformation of said at least one productwithout shape memory into a product having shape memory whichspontaneously models itself on the patient's face.

Further characteristics and advantages of the present invention willbecome apparent from the description of some preferred but not exclusiveembodiments, illustrated only by way of non-limitative example in theaccompanying drawings, wherein:

FIG. 1 is a schematic sectional view of a customizable mask with twoseparate containers for two products which can be mixed to provide amaterial without shape memory;

FIG. 2 is a schematic view of the step for the self-modeling of themask;

FIG. 3 is a schematic view of the mask with the two components of thereaction provided in two separate regions;

FIG. 4 is a schematic sectional view of the mask in which it is possibleto introduce a self-modeling material;

FIG. 5 is a schematic view of the mask applied to a patient.

With reference to the above figures, the customizable face or nose maskfor the noninvasive ventilation of patients in general, generallydesignated by the reference numeral 1, comprises a mask body 2 which hasat least one surface portion 3 which can be coupled to the face of thepatient.

The surface portion is preferably provided by a flexible element whichinternally delimits a region or chamber containing at least one productwithout shape memory.

In greater detail, it is possible to provide different embodiments, andin particular the chamber, as shown in the examples of FIGS. 1 and 2, isconstituted by a first region 10 and by a second region 11 which areseparated one another by a breakable membrane 12.

The first region 10 and the second region 11 contain a first product anda second product which, when the breakable membrane 12 is broken, reacttogether, producing a product having shape memory which self-models onthe face of the patient.

In the embodiment shown in FIG. 3, the chamber is provided by means of afirst container 20 which is separated, by means of a breakable partition21, from at least one second container 22 on which there acts a plungerfor pushing the second component, which can be introduced in the firstcontainer 20, where there is a first component which reacts chemicallyso as to obtain a product having shape memory.

According to FIG. 4, a chamber 30 is provided which is delimited by theflexible plate-like element 3 forming the surface portion for couplingto the face of the patient and which is equipped with an inlet 31 inwhich it is possible to couple a nozzle for introducing a component orbinary component, in the form of foam or in another form, which reactsdirectly inside the chamber 30, providing a product having shape memorywhich self-models on the face of the patient.

Essentially, the material or binary materials, by setting, assume theshape of the container, which is delimited in practice by the flexiblesheet-like element which, in contact with the face of the patient,shapes the product so as to provide a truly customized mask.

Once the chemical or physical reaction has occurred, the hardness of thematerial is not very important in itself, since it is possible to useboth a rigid material, by providing soft sealing elements on theflexible sheet-like element, and a soft material, which directly acts asa gasket.

Usable materials belong to a wide range; in particular, it is possibleto use all materials which can lead to a chemical or physical reactionwhich alters their state from fluid without memory, or in any case froma material having no shape of its own, into a solid or gel which hasmemory, i.e., can resume its own shape.

Merely by way of example, mention is made of polyurethanes, which assumethe intended shape when the two components are mixed, gelledwater-soluble polyurethanes, foams, and so forth.

When the reaction occurs, the temperature during setting should notexceed 40° C. in view of the fact that said setting occurs in contactwith the skin.

Moreover, the recommendable duration of the setting process must be onthe order of no more than 5-10 minutes, since this is considered to bean acceptable time for which the patient can keep the mask on his facewithout moving it during the reaction of the components.

From the above description it is thus clear that the invention achievesthe intended aim and objects; in particular, it is stressed that acustomizable mask is provided which can be shaped directly in contactwith the patient's face without having to resort to all the complicatedoperations which are typical of the solutions of the prior art.

The invention thus conceived is susceptible of numerous modificationsand variations, all of which are within the scope of the inventiveconcept.

All the details may furthermore be replaced with other technicallyequivalent elements.

In practice, the materials employed, as well as the contingent shapesand dimensions, may be any according to requirements.

1. A customizable face or nose mask for noninvasive ventilation of patients in general, comprising: a mask body forming at least one surface portion which can be coupled to a patient's face, said mask body having a chamber for containing a product which can be activated to transform said product into a solid or gel product which spontaneously models to the patient's face to form a customized seal of the mask body to the patient's face.
 2. The mask according to claim 1, wherein said surface portion that can be coupled to the face of the patient comprises a flexible element.
 3. The mask according to claim 1, wherein said product comprises a first component and a second component, and said chamber comprises a first container containing said first component and a second container containing said second component, said first container being separated by a breakable membrane from said second container, and wherein said chamber further comprises means for breaking said breakable membrane to cause said first and second components to transform said product into said solid or gel product. 